ESLICARBAZEPINE ACETATE

Other

Brand names: Eslicarbazepine Acetate

Oral

Mechanism of Action

12.1 Mechanism of Action Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.

Indications

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Contraindications

• 4 CONTRAINDICATIONS Eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2
• 5.3
• and 5.4 )]. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior
1 ) • Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Anaphylactic Reactions and Angioedema: Monitor and discontinue if another cause cannot be established
4 ) • Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms
6 ) • Withdrawal of eslicarbazepine acetate: Withdraw eslicarbazepine acetate gradually to minimize the risk of increased seizure frequency and status epilepticus

Known Side Effects

9 documented side effects by frequency

Drug Not Working

1-10%

Dizziness

1-10%

Drowsiness

1-10%

Fatigue

0.1-1%

Headache

0.1-1%

Falls

0.1-1%

Nausea

0.1-1%

Rash

0.1-1%

Condition Worsened

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral